FDA Adverse Event Injury Summary report: N

LASIK DEVICE

MDR report key: 20373010 · Received October 3, 2024

Report

Report Number
MW5160653
Event Type
Injury
Date Received
October 3, 2024
Date of Event
February 28, 2008
Report Date
September 28, 2024
Manufacturer
UNKNOWN
Product Code
LZS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NH, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

POST LASIK CORNEAL NEUROPATHIC PAIN- SEVERE DRY EYE PAIN- CORNEAL NEURALGIA LASIK SHOULD NOT BE APPROVED BY THE FDA! IT IS TOO RISKY! AS YOU AGE, ESPECIALLY WOMEN, HORMONES CHANGE WORSENING DRY EYE SYMPTOMS AND OVERALL EYE PAIN! VERY SAD ABOUT THIS. I HAD LASIK IN (B)(6) LASIK CENTER IN (B)(6) 2008. THEY MADE LASIK SOUND SO QUICK, EASY, AMAZING, LIFE CHANGING AND AFFORDABLE. THEY DID NOT GIVE ME A CHANCE TO SIT DOWN AND TALK WITH THE SURGEON BEFORE THE PROCEDURE TO DISCUSS THE POSSIBLE SIDE EFFECTS AND RISKS ETC. THE DR. DID NOT MENTION THE POSSIBILITY OF DRY EYE OR ANY SIDE EFFECT UNTIL I WAS LYING ON THE OPERATING TABLE, AND I ASKED HIM ABOUT POSSIBLE SIDE EFFECTS¿ AND THEN IT SEEMED TOO LATE.... THIS SURGERY SHOULD NOT BE LEGAL- ESPECIALLY FOR WOMEN. THE DOCTORS NEED TO BE REQUIRED TO EQUALLY EXPLAIN THE RISKS OF CORNEAL NEUROPATHIC PAIN AND DRY EYE AND NOT DOWNPLAY THESE SYMPTOMS. I PRAY TO GOD FOR HEALING! THANKFULLY HE IS HELPING ME THRU THIS. I HAVE BEEN TO 5 INTENSE PULSED LIGHT TREATMENTS, MULTIPLE OPHTHALMOLOGIST APPOINTMENTS, URGENT CARE VISIT- TAKE MAGNESIUM SUPPLEMENTS, EYE DROPS THROUGHOUT THE DAY AND EYE OINTMENT AT NIGHT TO HELP WITH SLEEP QUALITY. I PRAY FOR A MIRACULOUS HEALING. I KNOW (B)(6) OUR HEALING GOD IS ABLE, BUT PLEASE AT MINIMUM PUT A WARNING ATTACHED TO LASIK- SO PEOPLE ARE NOT COMPLETELY DECEIVED AND NAÏVE TO THE VERY REAL RISKS AND SIDE EFFECTS... ESPECIALLY AS A WOMAN AGES!!! I TRY TO LOOK ON THE BRIGHT SIDE AND THANK GOD IT IS NOT WORSE, BUT I WOULD NOT RECOMMEND LASIK FOR ANYONE! IT SHOULD BE ILLEGAL!!!! DO NOT APPROVE IT ANY LONGER PLEASE AND THANK YOU. THERE SHOULD BE A HUGE WARNING LABEL ATTACHED TO IT LIKE THERE IS FOR SMOKING CIGARETTES. PLEASE USE WISDOM BEFORE APPROVING ELECTIVE/ NON-MEDICAL PROCEDURES LIKE LASIK. FROM AGE 30- TO ABOUT AGE 45 POST LASIK-THANK GOD, MY EYES FELT FINE FOR THE MOST PART- NO REAL ISSUES. BUT NOW, I HAVE EXPERIENCED INCREASED EYE PAIN AND DRY EYE. PRAYING FOR A HEALING!

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
53759 LASIK DEVICE EXCIMER LASER SYSTEM LZS UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 30 YR Female Disability| O FLAX SEED OIL M.ULTIVITAMIN/ MINERAL.| LEVOTHYROXINE.| MAGNESIUM.| MELATONIN.